NCT01129518

Can we Reduce the Number of Vaccine Injections for Children?

An Open Label Randomised Controlled Study to Evaluate the Induction of Immune Memory Following Infant Vaccination With a Glycoconjugate Neisseria Meningitidis Serogroup C Vaccine and to Assess the Immunological Impact of Administering Routine Infant Immunisations in Consistent Versus Alternating Limbs

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 404 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 2 Months – 3 Months
• Healthy volunteers: Accepted

Summary

This open label randomised controlled study will evaluate the induction of immunity following varying schedules of vaccination with glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccines in infancy. 498 infants will be enrolled in this multi-centre trial. Participants will receive either 0, 1, or 2 priming doses of a MenC-CRM197 conjugate vaccine or 1 priming dose of a MenC-TT conjugate vaccine in the first year of life, with all groups receiving a dose of a combination Hib-MenC-TT vaccine at 12 months, as well as all other concurrent routine vaccinations. All groups will also be further divided into 2 groups to receive their routine vaccines in either consistent or alternating limbs to assess the immune response to the concurrent infant routine immunisations administered in consistent versus alternating limbs. Immune responses will be assessed at 5, 12, 12months +6 days, 13 and 24 months of age.

Conditions

• Invasive Meningococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccine	In order to ensure proper intramuscular injection of the study vaccines, a 23G (0.5mm in diameter) needle of at least 1 inch (2.54 cm) length will be used. All vaccines will be administered intramuscularly. Then MenC vaccine will administered either once (at 3 months) or twice (at 3 and 4 months) depending on treatment group to either the thigh, deltoid or a combination of the two.
BIOLOGICAL	Routine schedule immunisations except monovalent MenC vaccine	Routine schedule immunisations will be given according to NHS guidelines.

Timeline

• Start date: 2010-06-01
• Primary completion: 2013-07-01
• First posted: 2010-05-24
• Last updated: 2015-11-09

Locations

1 site across 1 country: United Kingdom